Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Status:
Completed
Trial end date:
2016-06-21
Target enrollment:
Participant gender:
Summary
The objective of this trial is 1) to evaluate the safety and clinical acceptability of a
5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and
perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in
eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures
of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to
examine the efficacy of mupirocin in achieving persistent eradication of SA colonization
among infants residing in the ICU,defined as the absence of SA in cultures of the nares,
umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to
receive medical care as they otherwise would if they were not enrolled in the trial. The
study will be powered with a primary endpoint with 126 participants. Enrollment may continue
to 500 participants to power secondary and exploratory endpoints and assist design subsequent
studies.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)